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Alectinib

lorlatinib as the second-line or later therapy after failure of alectinib treatment as the firstline therapy

Lortlatinib

Pfizer CT.gov Call Center

To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer (NSCLC).

This study is a post-approval, company-sponsored, observational study. This study is a multicenter, non-interventional, retrospective, chart review of patients with ALK+ NSCLC patients treated using lorlatinib as the second/later line therapy in Japan after failure of alectinib treatment as the first line therapy from 20 November 2018.

All decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site. Patients in this study are those who started treatment with lorlatinib from 1 May 2019 to 31 December, 2020 in clinical practice.

Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients

Retrospective, Multicenter, Observational Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Age at start of lorlatinib treatment was entered based on the data in medical chart. If there were no details about the applicable age, the age was calculated from the date of birth to the start date of lorlatinib treatment.

ECOG PS is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled and Grade 5: dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG PS were presented. Participants whose ECOG PS was not known were reported under category "Unknown".

Number of participants according to NSCLC histopathological subtype (adenocarcinoma, squamous cell carcinoma and adenosquamous epithelial carcinoma) were reported in this outcome measure.

Number of participants according to sites of metastasis at start of alectinib treatment were presented in this outcome measure. One participant could have more than one site of metastases.

Number of participants according to sites of metastases at start of lorlatinib treatment were presented in this outcome measure. One participant could have more than one site of metastases.

Number of participants with previous medical history related to history of treatment for ALK+ NSCLC were reported in this outcome measure.

Number of participants with previous medical history of high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure.

Complication was defined as a disease or disorder arising as a consequence of another disease. Number of participants according to presence of complications were reported in this outcome measure.

Number of participants who developed complications such as high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure. One participant may have more than one complication.

The Brinkman index (BI) is a measure of cigarette smoke exposure and is used as a predictor of chronic obstructive pulmonary disease (COPD) in smokers. It is calculated as the number of cigarettes smoked per day multiplied by the number of years of smoking. The scores ranged from 20 to 1050, where higher scores indicated higher cigarette smoke exposure.

ALK test was used to detect specific rearrangements in the ALK gene in cancer cells and tissue. Number of participants with ALK test result were reported in this outcome measure.

Number of participants according to the type of ALK testing methods including immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), reverse transcription polymerase chain reaction (RT-PCR) and other methods were presented in this outcome measure. One participant may have more than one type of ALK testing method.

Number of participants for whom dates of performing ALK test was available was presented in this outcome measure.

Number of participants according to treatment administered (Anaplastic Lymphoma Kinase- Tyrosine Kinase Inhibitor \[ALK-TKI\] including brigatinib, ceritinib and crizotinib or Other chemotherapy\]) for NSCLC prior to start of lorlatinib treatment were presented in this outcome measure.

Time to treatment failure (TTF) was the time from the first date of lorlatinib treatment to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. Disease progression (PD) was defined in a method that complied with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.

Objective response rate was defined as the percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 from first date lorlatinib treatment until date of treatment discontinuation. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures \<10 mm. PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement.

Time to treatment failure was the time from the first date of alectinib treatment to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.

Time to treatment failure was the time from the first date of the other subsequent treatment to the date of other subsequent treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.

Objective response rate was defined as the percentage of participants with BOR of either CR or PR according to RECIST version 1.1 from the first date of alectinib until the date of treatment discontinuation. CR = disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, both target and non-target must have short axis measures \<10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement.

Combined TTF is defined as sum of the time from the first date of alectinib to the date of any-cause alectinib discontinuation, the time from the first date of lorlatinib to the date of lorlatinib discontinuation and the time from the first date of the other subsequent treatment to the date of other subsequent treatment discontinuation. If participants continued treatment, combined TTF was censored at the available last date of treatment or the study end period. Combined TTF was analyzed using Kaplan-Meier method.

Time to last treatment failure (TLTF) is the time from the first date of lorlatinib to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death in the last treatment. If participants continued treatment, TLTF was censored at the available last date of treatment or the study end period. PD was defined as \>= 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm and appearance of one or more new lesions. TLTF was analyzed using Kaplan-Meier method.

Pfizer

This observational retrospective study retrieved data from medical records and the data existed as unstructured data. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event could not be met, hence safety data were not collected and reported.

Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.

Lorlatinib 2L

Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.

Lorlatinib 3L or Later

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Full analysis set (FAS) comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Pfizer ClinicalTrials.gov Call Center

FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.

Age at Start of Lorlatinib Treatment

FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Height at Start of Alectinib Treatment

Height at Start of Lorlatinib Treatment

Weight at Start of Alectinib Treatment

Weight at Start of Lorlatinib Treatment

Body Mass Index (BMI) at Start of Alectinib Treatment

BMI at Start of Lorlatinib Treatment

Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment

Number of Participants According to ECOG PS at Start of Lorlatinib Treatment

Number of Participants According to NSCLC Histopathological Subtype

Number of Participants According to Presence of Metastases at Start of Alectinib Treatment

Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment

Ipsilateral lung

Contralateral lung

Lymph node affiliation

Remote lymph node

Liver

Bone

Brain

Adrenal glands

Kidney

Other

Number of Participants According to Sites of Metastases at Start of Alectinib Treatment

Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment

Number of Participants According to Presence of Previous Medical History

High blood pressure

Diabetes

Hyperlipidemia

Number of Participants According to Details of Previous Medical History

Number of Participants According to Presence of Complications

Number of Participants According to Details of Complications

Number of Participants According to Smoking History

Brinkman Index Score

Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result

FISH

RT-PCR

Number of Participants According to Type of ALK Testing Method

Number of Participants for Whom Dates of ALK Test Was Available

ALK-TKI

Other chemotherapy

FAS: participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in first line setting in a medical record. Only participants with any prior therapy for NSCLC other than alectinib as first line were analysed. All participants in Lorlatinib 2L arm were administered first line treatment of alectinib and did not receive any prior therapy for NSCLC other than alectinib.

Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment

Time to Treatment Failure for Lorlatinib as the Second Line Therapy and the Third or Later Line Therapy

Progression disease

Adverse event

Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib

Objective Response Rate for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy

Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line or later line therapy from 01-May- 2019 to 31-Dec-2020 in clinical practice after failure of alectinib treatment as the first line therapy were included.

Overall Participants

Time to Treatment Failure for Alectinib as the First-Line Therapy: Overall Participants

Time to Treatment Failure for Subsequent Other Treatment

Objective Response Rate for Alectinib

Combined Time to Treatment Failure of the Sum of Alectinib and Subsequent Therapy Including TTF of Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy

Spots Global Cancer Trial Database for lortlatinib

Every month we try and update this database with for lortlatinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lortlatinib

Every month we try and update this database with for lortlatinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lortlatinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.